Musculoskeletal News Roundup 17-Nov-17

November 17, 2017
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Blake Mossy

REVENUES

Alphatec Holdings a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, announced today financial results for its third quarter ended September 30, 2017 and recent corporate highlights. Total revenue of $23.1 million; U.S. commercial revenue of $20.7, U.S. commercial revenue for the third quarter of 2017 was $20.7 million, down $1.2 million compared to $21.9 million in the second quarter of 2017. U.S. gross profit and gross margin for the third quarter of 2017 were $14.3 million and 69.1%, respectively, compared to $15.5 million and 70.9%, respectively, for the second quarter of 2017. The decrease in gross margin was due to lower sales volume, changes in product mix, and the impact of variations in inventory write-offs as the Company continues to optimize its supply chain.

DJO Global reported financial results for 3Q:17. Total revenue was $290.9 million in 3Q:17, increasing 0.3% compared to $287.0 million in 3Q:16. Adjusted EBITDA was $57.2 million in 1Q:17, increasing 15% from $48.9 million in 1Q:17. Adjusted EBITDA margin increased to 23.0% in 3Q:17 from 22.1% in 3Q:16. The company's segments grew by: Bracing & Vascular (7.4%), Recovery Sciences (1.4%) and Surgical Implant +12% in 3Q:17 respectively. International revenues increased by 6% in 1Q:17 compared to 1Q:16 and represented 26% of total revenue in 3Q:17. All growth rates are on a constant currency basis.

Mazor Robotics reported financial results for 3Q:17. Total revenue was $17.2 million in 3Q:17, increasing 126% compared to $7.6 million in 3Q:17. Revenue generated in the U.S. increased from $5.7 million in 3Q:16 to $15.4 million in 3Q:17, selling seventeen of its Mazor X systems. International non-U.S. revenue decreased from $1.9 million in 3Q:16 to $1.8 million in 3Q:17. Revenue from system kit sales, services & other was $7.0 million in 3Q:17, representing a 63% increase compared to $4.3 million in 3Q:16. Gross margin for 3Q:17 increased to 69.2%, from 65.7.2% in 3Q:16. All growth rates are on a reported basis.

Vericel reported financial results for 3Q:17. Total revenue was $14.3 million in 3Q:17, beating consensus estimates by 7% and representing a increase of 30% compared to $10.9 million in 3Q:16. Net revenue for the company's MACI (autologous cultured chondrocytes on porcine collage membrane) implants and Epicel (cultured epidermal autografts) and Carticel (autologous cultured chondrocytes) product revenues were $9.9 million and $4.4 million and $8.3 million in 3Q:17.. Gross margin for 3Q:17 increased to 77.6% from 37.6% in 3Q:16. All growth rates are on a reported basis.

FUNDING

Diamond Orthopedic secured $3.5 million seed round of equity funding led by MagnaSci Fund LP. The new capital will be used to support the company’s technology, a faceted threadform designed to reduce friction and compressive stress at the bone-screw interface, thus reducing the risk of microfractures.

REGULATORY

Extremity Medical received 510(k) clearance from the FDA for its Omni MTP, a fusion system that provides all traditionally used methods for fixation of the MTP joint for fusion. The system also utilizes the PlantarFiX system which is designed to generate consistent plantar-side compression across the arthrodesis site regardless of patient bone quality.

MedShape received 510(k) clearance from the FDA for its DynaNail XL TTC Fusion System, indicated for tibiotalocalcaneal (TTC) fusion surgery and designed for use in patients with longer tibial anatomies or those with prior failed fusion procedures using and intramedullary nail. The system employs pseudoelastic properties of Nitinol to provide compression like that of an external frame.

Mortise Medical received 510(k) clearance from the FDA for its SyndesMetrics Syndesmosis Repair system, designed to support predictable/repeatable anatomic reduction, restoration of physiological motion and restoration of ankle stability. The systems requires minimal hardware prominence, no suture prominence and a reversible locking mechanism for securing the high strength suture tape that connects the tibial and fibular implant components.

DISTRIBUTION

OrthoPediatrics and Bioretec announced that they have amended their existing distribution agreement in order for OrthoPediatrics to market and sell Bioretec’s bioresorbable orthopedic bone and soft-tissue fixation implant under OrthoPediatrics brand, TorqLoc. The system is indicated for the treatment of musculoskeletal defects and trauma related bone and soft-tissue injuries in children and young people.

CLINICAL

Titan Spine announced the first surgeries completed using its Endoskeleton interbody fusion devices and surface technology in Australia. The company received registration approval from the Australian Therapeutic Goods Administration (TGA) in 2014 and the New Zealand Medicines and Medical Devices Safety Authority to commercially market its line of Endoskeleton devices.